Device for the in-situ delivery of heart valve prosthesis

Abstract

Disclosed herein is a deployment instrument including: a shaft ( 2 ) having a longitudinal axis (X 1 ); a handle ( 3 ) at a first end of the shaft ( 2 ); and a carrier portion ( 4 ) at a second end of the shaft ( 2 ). The carrier portion ( 4 ) is configured for holding an expandable heart valve prosthesis in a radially collapsed condition for delivery to the implantation site. The carrier portion ( 4 ) includes a hub ( 5 ) fixed to the handle ( 3 ) via the shaft ( 2 ), a first deployment element ( 6 ) and a second deployment element ( 7 ), each of said first deployment element ( 6 ) and second deployment element ( 7 ) configured to hold a corresponding portion of an expandable heart valve N prosthesis in a radially collapsed condition. A drive member ( 8 ) is provided which is configured to operate the first deployment element ( 6 ) and the second deployment element ( 7 ) in first and second opposite directions. The instrument is also provided with a mechanism to allow a displacement of the second deployment element in the second direction independently of the drive member ( 11 ).

The invention claimed is: 
     
       1. A deployment instrument for expandable heart valve prostheses including:
 a shaft having a longitudinal axis; 
 a handle at a first end of the shaft; and 
 a carrier portion at a second end of the shaft, the carrier portion configured for holding an expandable heart valve prosthesis in a radially collapsed condition for delivery to the implantation site, 
 wherein:
 the carrier portion includes a hub fixed to the handle via the shaft, a first deployment element and a second deployment element, each of said first deployment element and second deployment element configured to hold a corresponding portion of an expandable heart valve prosthesis in a radially collapsed condition, 
 the handle comprises a drive member including a first drive feature and a second drive feature, 
 the first deployment element of the carrier portion is connected to a first axially movable element, the first axially movable element engaging said first drive feature of the drive member, 
 the second deployment element of the carrier portion is connected to a second axially movable element, the second axially movable element engaging said second drive feature of the drive member, 
 wherein operation of the drive member is configured to simultaneously actuate both the first drive feature to axially displace the first deployment element in a first direction and the second drive feature to axially displace the second deployment element in a second direction, said first direction and said second direction being opposite to one another, and 
 further wherein the second axially movable element includes a first portion and a second portion, the first portion engaging the second drive feature, and the second portion being axially movable relative to the first portion to provide an axial displacement of the second deployment element in the second direction independently of the drive member. 
 
 
     
     
       2. The deployment instrument of  claim 1 , wherein the first end of the shaft is a proximal end, and the second end of the shaft is a distal end. 
     
     
       3. The deployment instrument of  claim 1 , wherein the first direction is a distal direction, and the second direction is a proximal direction. 
     
     
       4. The deployment instrument of  claim 1 , wherein said first drive feature comprises a first threaded portion and said second drive feature comprises a second threaded portion. 
     
     
       5. The deployment instrument of  claim 4 , wherein said drive member is a rotary drive member comprising a knob and a stem, the first drive feature being provided on a first surface of the stem, and the second drive feature being provided on a second surface of the stem. 
     
     
       6. The deployment instrument of  claim 1 , wherein the first portion and the second portion of the second axially movable element are partly overlapping and slidably coupled to one another. 
     
     
       7. The deployment instrument of  claim 6 , the second axially movable element including an elastic element biasing the second portion away from the first portion. 
     
     
       8. The deployment instrument of  claim 1 , wherein the shaft has a layered structure. 
     
     
       9. The deployment instrument of  claim 8 , wherein the shaft includes:
 a first shaft member as middle layer; 
 a second shaft member as outer layer; and 
 a rod or shaft member as a core, 
 wherein:
 the first shaft member connects the hub of the carrier portion to the handle, 
 the second shaft member connects the second deployment element to the second axially movable element, 
 the rod or shaft member connects the first deployment element to the first axially movable element. 
 
 
     
     
       10. The deployment instrument of  claim 9 , wherein the second shaft member is engaged by diametrically opposite axial extensions protruding from an annular member of the second axially movable element. 
     
     
       11. A deployment instrument for expandable heart valve prostheses, including:
 a shaft having a longitudinal axis; 
 a handle at a first end of the shaft; and 
 a carrier portion at a second end of the shaft, the carrier portion configured for holding an expandable heart valve prosthesis in a radially collapsed condition for delivery to the implantation site, 
 wherein:
 the carrier portion includes a hub fixed to the handle via the shaft, a first deployment element and a second deployment element, each of said first deployment element and second deployment element configured to hold a corresponding portion of an expandable heart valve prosthesis in a radially collapsed condition, 
 the handle comprises a drive member including a first drive feature and a second drive feature, 
 the first deployment element of the carrier portion is connected to a first axially movable element, the first axially movable element engaging said first drive feature of the drive member, 
 the second deployment element of the carrier portion is connected to a second axially movable element, the second axially movable element engaging said second drive feature of the drive member, wherein upon operation of the drive member the first drive feature is configured to axially displace the first deployment element in a first direction, and the second drive feature is configured to axially displace the second deployment element in a second direction, said first direction and said second direction being opposite to one another, and 
 
 further wherein the second axially movable element includes a first portion and a second portion, the first portion engaging the second drive feature, and the second portion being axially movable relative to the first portion to provide an axial displacement of the second deployment element in the second direction independently of the drive member; 
 wherein said first drive feature comprises a first threaded portion and said second drive feature comprises a second threaded portion; 
 wherein said drive member is a rotary drive member comprising a knob and a stem, the first drive feature being provided on a first surface of the stem, and the second drive feature being provided on a second surface of the stem; and 
 wherein said stem is a hollow member, said first drive feature being provided on an inner surface of the stem, and said second drive feature being provided on an outer surface of the stem. 
 
     
     
       12. A deployment instrument for expandable heart valve prostheses, including:
 a shaft having a longitudinal axis; 
 a handle at a first end of the shaft; and 
 a carrier portion at a second end of the shaft, the carrier portion configured for holding an expandable heart valve prosthesis in a radially collapsed condition for delivery to the implantation site, 
 wherein:
 the carrier portion includes a hub fixed to the handle via the shaft, a first deployment element and a second deployment element, each of said first deployment element and second deployment element configured to hold a corresponding portion of an expandable heart valve prosthesis in a radially collapsed condition, 
 the handle comprises a drive member including a first drive feature and a second drive feature, 
 the first deployment element of the carrier portion is connected to a first axially movable element, the first axially movable element engaging said first drive feature of the drive member, 
 the second deployment element of the carrier portion is connected to a second axially movable element, the second axially movable element engaging said second drive feature of the drive member, wherein upon operation of the drive member the first drive feature is configured to axially displace the first deployment element in a first direction, and the second drive feature is configured to axially displace the second deployment element in a second direction, said first direction and said second direction being opposite to one another, and 
 
 further wherein the second axially movable element includes a first portion and a second portion, the first portion engaging the second drive feature, and the second portion being axially movable relative to the first portion to provide an axial displacement of the second deployment element in the second direction independently of the drive member; 
 wherein the first portion includes:
 an annular portion wherefrom a first pair of diametrically opposite axial extensions protrude; and 
 an internal thread provided on the cylindrical inner surfaces of the axial extensions of the first pair and the annular member, the internal thread being configured to engage the second drive feature, 
 wherein the axial extensions merge at a flange wherefrom a second pair of diametrically opposite axial extensions departs axially away from the first pair of axial extensions. 
 
 
     
     
       13. The deployment instrument of  claim 12 , wherein the axial extensions of the second pair are arranged at a location at right angle relative to the axial extensions of the first pair. 
     
     
       14. The deployment instrument of  claim 12 , wherein each axial extension of the second pair includes a through axial slot, the axial extensions of the second pair being separated by a pair of axial grooves. 
     
     
       15. The deployment instrument of  claim 12 , wherein the second portion of the second axially movable element includes an annular member wherefrom a third pair of diametrically opposite axial extensions protrude. 
     
     
       16. The deployment instrument of  claim 15 ,
 wherein the axial extensions of the third pair have the same position as the axial extensions in the second pair, and are each provided with a radially protruding plug, 
 wherein a pair of radially protruding teeth, diametrically opposite, extend from an inner surface of the annular portion and inwardly of the same, while a pair diametrically opposite guide fingers extend axially at said annular portion at positions at right angles relative to those of the radially protruding teeth, and 
 wherein the guide fingers are aligned with a corresponding through axial slot and slidably engage the same, while the teeth are aligned with the grooves separating the axial extensions of the second pair and are slidable therethrough. 
 
     
     
       17. A deployment instrument for expandable heart valve prostheses including:
 a shaft having a longitudinal axis; 
 a handle at a first end of the shaft; and 
 a carrier portion at a second end of the shaft, the carrier portion configured for holding an expandable heart valve prosthesis in a radially collapsed condition for delivery to the implantation site, 
 wherein:
 the carrier portion includes a hub coupled to the handle via the shaft, a first deployment element and a second deployment element, each of said first deployment element and second deployment element configured to hold a corresponding portion of an expandable heart valve prosthesis in a radially collapsed condition, 
 the handle comprises a drive member that simultaneously causes a first drive feature to axially displace the first deployment element in a first direction and a second drive feature to axially displace the second deployment element in a second, opposite, direction. 
 
 
     
     
       18. The deployment instrument of  claim 17 , wherein the second deployment element is coupled to the second drive feature by a second axially movable member that includes a first portion and a second portion, the first portion engaging the second drive feature, and the second portion being independently axially movable relative to the first portion. 
     
     
       19. The deployment instrument of  claim 17 , wherein the first drive feature comprises a first threaded portion having first winding threads and the second drive feature comprises a second threaded portion having second winding threads, opposite the first winding threads.